A clinical study for evaluating the effects of food containing lactic acid bacteria on immune function. - A randomized, double-blind, placebo-controlled, parallel-group comparative method - - A clinical study for evaluating the effects of food containing lactic acid bacteria on immune function.

KSO Corporation0 sites200 target enrollmentSeptember 8, 2022

ConditionsHealthy Adults

Overview

Phase: 未知
Intervention: Not specified
Conditions: Healthy Adults
Sponsor: KSO Corporation
Enrollment: 200
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 8, 2022

End Date

April 24, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

KSO Corporation

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Subjects (who) 1\. suffering from, undergoing treatment for, or with a history of serious diseases. 2\. have chronic diseases and take medication on a daily basis. 3\. have been diagnosed as dry mouth. 4\. are unable to abstain from taking supplement, food for specified health use or functional food, or health food that may affect immune function. 5\. are unable to abstain from taking food that containing lactic acid bacteria, bifidobacterium, oligosaccharides, or viable bacteria during the study. 6\. consistently drink more than the appropriate amount of alcohol. 7\. are unable to abstain from alcohol for 2 days prior to screening test and each test. 8\. have food allergies. 9\. take or have the plan to take medicine for pollen allergy. 10\. with digestive diseases affecting digestion and absorption and with a history of digestive surgery (excluding appendicitis). 11\. tend to get diarrhea by taking dairy products. 12\. are pregnant women, women who intend to become pregnant during the research period, and women who are breastfeeding. 13\. are judged to be inappropriate as research subjects by blood tests in screening tests. 14\. have a history or current condition of drug or alcohol dependence. 15\. are participating in research involving the ingestion of other foods or the use of other medicines or who have participated within one month of obtaining consent, and those who are willing to participate. 16\. are judged to be inappropriate as research subjects by the principal investigator. 17\. smoke 21 or more cigarettes a day. 18\. have the plan to receive the influenza vaccine from 3 weeks before ingestion to the end of the ingestion period. 19\. have the plan to receive the COVID\-19 vaccine during the ingestion period. 20\. work on night shift. 21\. plan to travel abroad during the study. 22\. has donated more than 200 mL of blood within 1 month or 400 mL of blood within 3 months prior to the date of obtaining consent, or donated blood components.